THIS WEEK'S ARTICLES
Updated Endoscope Reprocessing Guideline Released
A multi-society task force details the required steps of proper high-level disinfection.
In January, leading gastroenterological societies released updated guidance on the reprocessing of flexible endoscopes. The document acknowledges that the devices are complex and require meticulous cleaning based on a multidisciplinary team-based approach, and offers these key recommendations:
- Reprocessing techs must receive training specific to the scope models they clean and high-level disinfect, and should have documented competencies in scope reprocessing before being assigned the task.
- Point-of-use treatment should begin as soon as endoscopes are no longer needed during procedures and before the scopes are transported to the reprocessing area. This important first step removes fluid and debris from external and internal surfaces to prevent biofilm from developing.
- Leak testing should occur after the bedside treatment and before manual cleaning of the scopes, and should be based on the scope manufacturers' instructions for use (IFU).
- The manual cleaning of scopes should include brushing all valves, channels, connectors and detachable parts with scope-specific brushes that are appropriately sized to come in contact with all surfaces and orifices.
- High-level disinfection should occur in an automated endoscope reprocessor with a disinfectant cleared by the FDA for use in the device. The disinfectant's label claims for exposure time and temperature must be followed, and must be compatible with the scopes being reprocessed.
- Scopes must be thoroughly dried at the end of the high-level disinfection cycle and before being placed in storage. Reprocessing technicians must use a clean, lint-free cloth to dry the exterior surfaces and flush inner channels with forced air. Ethyl and isopropyl alcohol can also be used to dry internal channels if recommended by the scope's IFU.
- Disinfected and dried scopes should be stored in secure cabinets that are housed outside of procedure rooms. Scopes should also be hung so that moisture does not collect in channels. Specialized cabinets with active channel-drying mechanisms or conventional cabinets with circulating, filtered air help to ensure scopes remain dry until their next use.
Check out the full guideline for the latest best practices in proper endoscope care.
Survey Reveals Knowledge Gap in Endoscope Care
The findings suggest many endoscopy professionals lack formal training in turning around scopes safely.
Very few frontline endoscopy professionals receive formal training in proper endoscope reprocessing practices, according to a recent survey published in the American Journal of Infection Control. The survey involved 88 endoscopy technicians and nurses who were asked about their experience and knowledge of endoscope care and infection prevention practices.
Although 90% of the endoscopy professionals surveyed expressed confidence in their abilities to reprocess endoscopes properly, their average score on a competency test of best practices in endoscope reprocessing given as part of the survey was just 62%. Many techs said they began reprocessing scopes independently within a month of employment, and most had not been certified to perform the task.
The survey's results highlight the need for comprehensive training and oversight of endoscope reprocessing practices. Tammy Richardson, RN, BSN, MHA, executive director at Community Endoscopy Center in Indianapolis, suggests conducting quarterly audits of staff involved in scope care. During audits, she says the following questions should be asked:
- Does staff don appropriate PPE?
- Is leak testing performed before high-level disinfection?
- Is the sink filled with water to the appropriate line during leak testing?
- Is leak testing performed for 30 seconds and is the scope angulated in all directions while submerged fully in water?
- Is the appropriate amount of detergent added to the water for manual cleaning?
- Are all channels on scopes brushed properly during manual cleaning?
- Does staff complete manual cleaning without pausing to handle a clean scope?
- Does staff check the fluid level of the high-level disinfectant in the AER?
- Does staff don a clean apron and gloves to remove scopes from the AER?
"Education and training are critical when it comes to endoscope reprocessing," says Ms. Richardson. "We make sure all endoscopy techs receive comprehensive education and training on handling our scopes. I also maintain an open-door policy and encourage staff to ask if they're ever in doubt about reprocessing protocols."
The Rise in GI Endoscopy Procedures Challenges the Processing Environment
Risks associated with biocide failure in the processing of flexible endoscopes are significant.
Endoscopy centers have become laser-focused on keeping procedure rooms fully scheduled to maximize the use of resources and patient throughput. This has a ripple effect throughout the chain of support services which enable supplies, capital equipment and instruments to be ready and available when the patient and physician are scheduled for an endoscopy procedure.
This is in no small part due to the rapid rise in endoscopy procedure volumes over the past several years.1 According to a study published by iData in 2019, there were 31 million GI endoscopy procedures performed in the United States alone in 2018,2 and there is every reason to expect continued procedure growth over the next two to three years.
This rise in endoscope use places strain on an already challenged processing environment. Pressure to increase volumes of scopes prepared for the next procedure invites compromises in manual cleaning and disinfection procedures, which has been well documented in recent peer-reviewed research.3
According to Cori Ofstead, MSPH, in the American Journal of Infection Control, "Reprocessing failures can have dire consequences for patients, and infections have been associated with ureteroscopes, cystoscopes, bronchoscopes, colonoscopes, gastroscopes, and duodenoscopes."4
To meet the increased procedure demand, endoscopy centers have responded with investment in tools and staff to manage the expanding workload. The automated endoscope reprocessor (AER) is playing a tireless role in ensuring endoscopes are available and properly disinfected as needed. Reprocessing flexible endoscopes in today's fast-paced clinical environment demands consistent, effective high-level disinfection (HLD) using AERs. Yet, despite advancements in technology over the last decade, AER operators are still required to manually test biocide minimum recommended concentration (MRC) levels during every cycle using a test strip.
If the biocide concentration level falls below the amount necessary to kill or activate microorganisms that are present in the scope, there can be a failure in AER's high-level disinfecting process. If this occurs, the biocide is said to have fallen below its MRC. The risks associated with biocide failure in the reprocessing of flexible endoscopes are significant. Non-compliance with proper MEC (an interchangeable term for MRC) testing protocols have negatively impacted patient outcomes.4 Additional studies have found GI endoscopy is an important risk factor for the transmission of CRE (Carbapenem-resistant Enterobacteriaceae and related superbugs.5,6
Manual MRC monitoring with test strips
While endoscopy procedure volume growth has prompted the purchase and use of more AERs, almost all AERs lack the ability to automatically test and track one of the most important variables in the HLD process: MRC monitoring. Other than the ASP AEROFLEX™ AER, the nearly universal method for MRC monitoring is the test strip, a chemical indicator that changes color in accordance with whether the concentration of biocide has crossed the MRC threshold.
Chemical indicator test strips have been in use since the 1950s for a variety of purposes, and in this case, they represent a weak link in the chain of requirements for consistent high-level disinfection of endoscopes. This is because with most AERs, MRC monitoring with a test strip is a step that can be easily missed or done incorrectly. Further, MRC test strips rely on regular staff interaction with the biocide, only deliver a pass/fail result (thus lacking the ability to rate concentration in levels or degrees), are susceptible to subjective interpretation by the AER operator, and provide no record of their correct use.
Adding to the difficulties associated with manual MRC monitoring is the lack of an electronic record of the task. The MRC test strip yields only a small patch of color change on a piece of aper which must be interpreted by an operator at the exact time interval to ensure an accurate result. Upon this manual reading rests the entire decision to reuse or replace the AER's biocide. Finally, these test results must be recorded manually by the technician to ensure compliance with guidlelines.7
With the introduction of the ASP AEROFLEX™ AER with AUTOSURE™ MRC Monitor, automatic MRC testing for every cycle is a standard feature, designed to increase compliance and patient safety and reduce the risk of healthcare-acquired infections during endoscopy procedures. The AUTOSURE™ MRC Monitor is a novel automated concentration measurement system grounded in mature chemistry and colorimetry.
The innovative AUTOSURE™ MRC Monitor is available exclusively on the ASP AEROFLEX™ AER and solves two critically-important issues faced by many GI labs: consistent, accurate MRC testing and record-keeping which ensures high-level disinfection and documentation compliance for every patient and every cycle, the AUTOSURE™ MRC Monitor reduces the opportunity for human errors related to manual test strip use.
Note: For more information, go to www.asp.com.
1. Everhart JE. The burden of digestive disease in the United States. U.S. Department of Health and Human Services 2008: NIH Publication No. 09-6443.
2. iData Corp., 2019 Gastrointestinal Endoscopic Devices Market Analysis, Size, Trends, United States, 2019-2025, MedSuite
3. Ofstead, Cori L., MSPH, et Al. Endoscope Reprocessing Methods: A Prospective Study on the Impact of Human Factors and Automation. Gastroenterology Nursing, Volume 33 | Number 4 | July/August 2010
4. C.L. Ofstead et al. / American Journal of Infection Control (2019) 1−7, Accessed 12/12/2019 www.ajicjournal.org/article/S0196-6553(19)30849-1/fulltext
5. Rutala et al., 2008; ASGE Standards of Practice Committee et al., 2008; AAMI, 2010
6. Muscarella LF. Risk of transmission of carbapenem-resistant Enterobacteriaceae and related "superbugs" during gastrointestinal endoscopy. World J Gastrointest Endosc 2014; 6: 457-474
7. The Joint Commission (TJC) The High-Level Disinfection (HLD) and Sterilization BoosterPak, 2017
Raising the Standards of Endoscope Storage
Specially designed cabinets are an important part of the reprocessing process.
Hanging endoscopes in state-of-the-art storage cabinets is a suitable end to their journey from procedure room to reprocessing area. The latest storage solutions keep scopes secure, safe and, perhaps most importantly, dry until they're needed again, says Linda Beaver, RN, MSN, MHA, administrator at Gateway Endoscopy Center in St. Louis.
Reprocessing technicians at her facility move scopes from automated endoscope reprocessors to storage cabinets with integrated drying technology that delivers HEPA-filtered air into individual scope channels. That targeted treatment with continuous pressurized air prevents moisture from forming in lumens, thereby decreasing cross-contamination risks.
Some of the latest scope storage cabinets also feature adjustable internal supports to maximize scope capacity while keeping them safely distanced, as well as secured access, padded surfaces to protect scopes from handling damage and durable finishes designed for easy cleaning.
Ms. Beaver says the storage cabinets also feature radio-frequency identification (RFID) technology. Technicians scan RFID tags on individual scopes as they're placed in storage. The tracking system electronically documents which hook a scope is hung on, the amount of time it remains in storage, and the technicians who placed and removed it from the cabinet. Ms. Beaver leverages the RFID technology to record the use of scopes in procedure rooms and to track their progress along each phase of the reprocessing process. The technology can even document which technicians reprocessed a scope and on which patients it was used.
"We believe our sterile processing techs have the most important job in our center," says Ms. Beaver. "Providing them with technologies designed to make their jobs easier is one way to keep them working hard behind the scenes at improving patient care."
Are Single-use Duodenoscopes the Answer?
Disposable devices eliminate concerns about properly cleaning the complex devices.
Single-use duodenoscopes are an effective alternative to reusable models in the hands of experienced physicians performing low-complexity endoscopic retrograde cholangiopancreatography procedures (ERCP), according to a study recently published in the journal Gut.
Disposable duodenoscopes have hit the market in an effort to eliminate cross-contamination risks and infection outbreaks linked to the difficult-to-clean reusable devices, say the study's authors, who point out performance in procedure rooms is a key factor in using the single-use scopes in practice.
In the study, which was published online in September 2020, 98 patients underwent low-complexity ERCP; 48 were treated with single-use scopes and 50 were treated with reusable models. The overall technical performance and safety profile were similar between single-use and reusable duodenoscopes, note the researchers. There was no significant difference in cannulation rates, but the median number of attempts physicians needed to achieve ductal access was significantly lower for single-use duodenoscopes.
Reusable duodenoscopes are difficult to clean properly — even when manufacturers' instructions for use are followed correctly — because of mechanical features incorporated into the distal tip, including a recessed space housing the scope's elevator wire cable. The study's authors note the complex design creates hard-to-reach areas that make thorough cleaning difficult, which enables biofilm to develop that protects microorganisms from high-level disinfection. Single-use scopes eliminate cleaning concerns, making the "innovation a significant advancement in the field of ERCP," say the researchers.